FDA.reportPublic FDA data

Quetiapine Fumarate

Product NDC
50090-3983
11-digit product format
500903983
Labeler code
50090
Product ID
50090-3983_51994a6c-153b-4f07-b3c9-4b7d2dfee326
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine Fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202674
Marketing category
ANDA
Marketing start
2016-07-01
Substance
QUETIAPINE FUMARATE
Active strength
300 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Quetiapine Fumarate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUETIAPINE FUMARATE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S3PL1B6UJ
Rxcui312745

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5ef42f82-f087-0d2c-105f-f791ca69210eProduct name820250729
21205abd-8c89-4943-9f85-908f3d4fc3bbProduct name520230501

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3983-02023-04-13C16284748780-1f386c64a-4739-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997
50090-3983-02023-01-30C16284748780-1f386c64a-4739-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3983-0Quetiapine Fumarate60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3983QUETIAPINE FUMARATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 1 package rows20230414_42bd7dd3-9f81-4d8b-bce9-302e5559da2f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312745QUEtiapine fumarate 300 MG Oral TabletPSN42bd7dd3-9f81-4d8b-bce9-302e5559da2f11
312745quetiapine 300 MG Oral TabletSCD42bd7dd3-9f81-4d8b-bce9-302e5559da2f11
312745quetiapine (as quetiapine fumarate) 300 MG Oral TabletSY42bd7dd3-9f81-4d8b-bce9-302e5559da2f11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3983-05009039830060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3983-0) 2018-12-170000-00-00NoNoCurrent